Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.
The agency expects to issue a decision by Aug. 31, and it is slated to decide on maintenance dosing for an intravenous form of the drug later this month.
Johnson & Johnson has agreed to acquire Intra-Cellular Therapies for approximately $14.6 billion, in the largest biopharma merger-and-acquisition (M&A) deal announced in two years.